Akebia tanks, as FDA declines to approve vadadustat for CKD

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to US biotech firm Akebia Therapeutics’ (Nasdaq: AKBA) New Drug Application (NDA) for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor under review for the treatment of anemia due to chronic kidney disease (CKD).

The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form, with the news sending Akebia’s shares tumbling 60% to $0.83 by close of trading on Wednesday.

The FDA concluded that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients. The FDA expressed safety concerns noting failure to meet non-inferiority in MACE in the non-dialysis patient population, the increased risk of thromboembolic events, driven by vascular access thrombosis in dialysis patients, and the risk of drug-induced liver injury. The CRL stated that Akebia could explore ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials. Akebia will discuss the details of the CRL with its collaboration partners and request a meeting with the FDA.